GRAIL to Showcase New Data for Galleri Multicancer Early Detection Test at Key Fall Meetings

GRAIL, Inc. will present results from more than 32,000 participants across 3 studies of its Galleri multi-cancer early detection (MCED) test at 2 major scientific meetings this fall.

_{Courtesy of GRAIL}

Initial data from the registrational PATHFINDER 2 study will be delivered as a late-breaking presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin. Updated findings from the SYMPLIFY and REFLECTION studies will follow at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon.

PATHFINDER 2 is the largest interventional MCED study conducted in the US in an intended-use population without clinical suspicion of cancer and was conducted under an FDA-approved investigational device exemption application. Top-line results from evaluable participants with 12 months of follow-up showed that adding Galleri to standard-of-care screening led to greater additional cancer detection and a higher positive predictive value (PPV) compared with the first PATHFINDER study, according to a GRAIL statement Accuracy of the cancer signal of origin and test specificity remained consistent with earlier findings.

At EDCC, GRAIL will report follow-up data from SYMPLIFY, a prospective observational study of symptomatic patients, as well as real-world experience from REFLECTION, which evaluated the test in veterans within the Veterans Affairs Healthcare System.

Detects 50 Types of Cancer

Galleri is a blood-based test that can detect more than 50 types of cancer before symptoms appear, with high accuracy in identifying the cancer signal of origin. Research has demonstrated that when used alongside standard cancer screening tools such as mammography, colonoscopy, prostate-specific antigen (PSA) testing, or cervical cancer screening, Galleri approximately doubles the number of cancers detected. According to GRAIL, Galleri also has the lowest false positive rate reported among MCED tests.

The test requires a prescription and is recommended for adults aged 50 or older or those with elevated cancer risk.

Transformative Era for Cancer Screening

“Galleri is the only available MCED test with demonstrated performance in an intended-use population being screened for cancer,” GRAIL president Josh Ofman, MD, MSHS, said in a statement. “These new data build on the results from our first clinical implementation study, PATHFINDER, which was published in the Lancet in 2023, and showed that Galleri approximately doubled the number of cancers identified when added to standard of care screening.

"We’re witnessing the beginning of a transformative era for cancer screening, with these results demonstrating Galleri’s ability to detect cancers earlier, when they can be easier to treat and are potentially curable,” Ofman added.

Additional ESMO presentations will include a poster on the use of Galleri for minimal residual disease detection in colorectal cancer. At EDCC, abstracts will cover long-term registry follow-up of false positive results in SYMPLIFY, baseline participant characteristics from PATHFINDER 2, and analyses comparing diagnostic work-up following Galleri testing with whole-body imaging approaches.

The results are expected to form part of GRAIL’s premarket approval application for Galleri to the FDA.

The company emphasizes that Galleri is not intended for individuals who are pregnant, younger than 21 years of age, or undergoing active cancer treatment. False positive and false negative results can occur, and results should always be interpreted in the context of a patient’s overall clinical picture.

GRAIL to present new Galleri data from more than 32,000 participants across the PATHFINDER 2, SYMPLIFY and REFLECTION studies at ESMO Congress 2025 and EDCC

Schrag D, Beer TM, McDonnell III CH, et al. .Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402(10409):1251-1260.